# K261289: UNiD™ Spine Analyzer (SW3002)

- Pathway: 510(k) (Special)
- Applicant: Medicrea International S.A.S. (Medtronic)
- Decided: May 15, 2026 after 25 days
- Product code: QIH (Automated Radiological Image Processing Software)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 14 generations back to K896095 (1990). 27 ancestors in all.
No later device cites it as a predicate yet.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251629: UNiD™ Spine Analyzer, Medicrea International S.A.S. (Medtronic) (2025) Summary page 6.

## Indications for use
The UNiD™ Spine Analyzer is intended for assisting healthcare professionals in viewing and measuring images as well as planning orthopedic surgeries. The device allows surgeons and service providers to perform generic, as well as spine related measurements on images, and to plan surgical procedures. The device also includes tools for measuring anatomical components for placement of surgical implants. Clinical judgment and experience are required to properly use the software.

Source page: https://510kreport.com/device/K261289
Methodology: https://510kreport.com/methodology